MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS LPS DIAPHYSEAL SLEEVE

Lot Number 1987-20-024

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problems Pain (1994); Swelling (2091); Arthralgia (2355)

Event Date 04/01/2016

Event Type  Injury  

Event Description

Had rt revision (knee).Dr (b)(6) installed depuy ortho revision on (b)(6) 2012.Received recall notice from fda in march 2013.Started having problems around (b)(6) 2016.Went through all this steps, finally got to (b)(6) dr (b)(6).Revised depuy was installed by dr (b)(6) in (b)(6) 2012 at (b)(6) hospital, (b)(6).Received recall notice in march 2013.I thought "great" because this is my 3rd revision.Dr (b)(6) told me that i don't have the luxury to do this again.Just not enough bone left on tibia and femur.Possibly tibia from cadaver.When started having problems with knee in about (b)(6) 2016, cracking, popping, swelling, hurt bad.Icc and pain meds.Went to primary to get referral to (b)(6) dr (b)(6).Dr (b)(6) didn't fill qualified to operate to remove and replace.Recalled rt knee.Recommended referral to (b)(6).Finally got appt at (b)(6) on (b)(6) 2016.(b)(6) took x-rays says dr (b)(6): he didn't fill qualified to continue exam on me.Dr (b)(6) told me that a senior partner was there that day, "dr (b)(6) being we are from out of town." we waited until dr (b)(6) brought dr (b)(6) up to speed on my knees.X-ray, bone scan, blood work etc.At this time, dr (b)(6) took over exam.After exam, his recommendation was to go home, come back in six months.His exact words were that he was afraid he would just make it worse.He called me as 50/50 chance that i would have worse range of motion, and, if infection sets in, he spoke in depth about amputation.I'm going to get 2nd opinion, apparently, dr at (b)(6) medical center in process as we write this to get appt.I have post-op x-rays from (b)(6) 2012 and (b)(6) 2016 to compare to show broken part.Have bone scan disc from (b)(6).

• Brand Name: LPS DIAPHYSEAL SLEEVE
• Type of Device: LPS DIAPHYSEAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS
• MDR Report Key: 6188842
• MDR Text Key: 62949549
• Report Number: MW5066810
• Device Sequence Number: 1
• Product Code: MBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1987-20-024
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 107